Overview
Randstad Sourceright, a leading provider of RPO & MSP Recruitment Services, is recruiting for a GxP Systems Engineer on behalf of a global CDMO organization.
Role Purpose: In this role you will be responsible for the management and support of Quality Control systems throughout their lifecycle:
* System/device specification
* Maintenance
You will collaborate with system owners and key members of the Quality, Operations and IT/OT teams in order to implement best-practice and integration with the site/global Infrastructure.
Responsibilities
* Front End
o Support implementation of OT hardware and infrastructure within QC environment
o Provide consultation with regards to software/systems implementation and validation.
o Define specifications and qualification requirements
o Work with vendors for initial qualification and facility requirements
o Identify current and emerging technologies which could benefit QC/add value and promote these opportunities internally.
* Business Partnering and Solution Provision
o Perform technical support and systems administration for QC systems.
o Provide consultation with regards to software/systems implementation and validation.
o Manage service contracts and routine maintenance activities for QC equipment/systems
o Manage spare parts and system up-time
o Provide hands-on system administration support (configuration, access management, system audit trails) for installed solutions
o Author GxP business and technical requirements for system management and control
o Train QC equipment users and Instrument Responsible people on systems
o Perform system periodic reviews
o Act as System Data Owner, ensuring integrity of data throughout the lifecycle and compliance with ALCOA+ principles
o Manage systems and data throughout the lifecycle, including risk management principles
Qualifications / Key Requirements
* Technical experience within GMP QC laboratory environment, including project management, equipment/system qualification/validation.
* Experience as Specialist / Super User / SME in a knowledge management software, electronic laboratory notebooks or laboratory information systems
* Ideally familiar with systems such as HPLC, ICP-OES, IC, XRPD.
* Focus on high quality; good at planning, organizing and communication.
* Empowerment, motivating others and development direction
* Understand operational technologies and data flows
* Experience developing system maintenance/resource/testing plans and costings
* Ability to work with Data: Analysis, trending and interpretation
* Ability to collaborate with broad cross functional teams
* Good Knowledge of Computer Systems Validation
* Knowledge of system implementation, documentation and maintenance.
* Ability to manage and execute multiple IT/OT tasks
* Experience of workstation, Server and Infrastructure administration and support
Seniority level
* Associate
Employment type
* Full-time
Job function
* Quality Assurance
Industries
* Pharmaceutical Manufacturing
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